FDA Inspection
Coty Lancaster SAMCoty Lancaster SAM – FDA Inspection, Sep 16, 2016
Record Details
This FDA Inspection record concerns Coty Lancaster SAM, with an inspection on September 16, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Coty Lancaster SAM
- Inspection Date
- September 16, 2016
- Product Type
- Drugs
View Company Profile
ID · d35a6900-9061-4388-989f-42df06c751ae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 989774
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(3)Statement of Sample Weights and Measures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
Showing 10 of 16 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Coty Lancaster SAM
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Coty Lancaster SAM
- FDA Inspection 819302 - 2013-02-01
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.